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NDC 41163-0724-07 Docosanol 100 mg/g Details

Docosanol 100 mg/g

Docosanol is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by EQUALINE (SuperValu). The primary component is DOCOSANOL.

Product Information

NDC	41163-0724
Product ID	41163-724_d32ff607-008e-46f3-94f8-918016489c62
Associated GPIs
GCN Sequence Number	047524
GCN Sequence Number Description	docosanol CREAM (G) 10 % TOPICAL
HIC3	Q5V
HIC3 Description	TOPICAL ANTIVIRALS
GCN	12866
HICL Sequence Number	021956
HICL Sequence Number Description	DOCOSANOL
Brand/Generic	Generic
Proprietary Name	Docosanol
Proprietary Name Suffix	n/a
Non-Proprietary Name	Docosanol
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	100
Active Ingredient Units	mg/g
Substance Name	DOCOSANOL
Labeler Name	EQUALINE (SuperValu)
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA208754
Listing Certified Through	2024-12-31

Package

Package Images

NDC 41163-0724-07 (41163072407)

Pricing Information	N/A
NDC Package Code	41163-724-07
Billing NDC	41163072407
Package	1 TUBE in 1 PACKAGE (41163-724-07) / 2 g in 1 TUBE
Marketing Start Date	2021-06-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7dd527af-878c-4150-86d0-69881b5e3f8f Details

Active ingredient

Docosanol 10%

Purpose

Cold sore/fever blister treatment

Uses

treats cold sores/fever blisters on the face or lips
shortens healing time and duration of symptoms:
tingling, pain, burning, and/or itching

Warnings

Allergy Alert: This product may cause a severe allergic reaction. Symptoms may include:

hives
facial swelling
wheezing/difficulty
shock
rash

If an allergic reaction occurs, stop use and seek medical help right away.

For external use only

Do not use

if you are allergic to any ingredient in this product

When using this product

apply only to the affected areas
do not use in or near the eyes
avoid applying directly inside your mouth
do not share this product with anyone. This may spread the infection.

Stop use and ask a doctor if

your cold sore gets worse or the cold sore is not healed within 10 days

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years or over:
- wash hands before and after applying cream
- apply to affected area on the face or lips at the first sign of cold sore/fever blister (tingle).
- early treatment ensures the best results
- rub in gently but completely
- use 5 times a day until healed
children under 12 years: ask a doctor

Other information

store at 20° to 25°C (68° to 77°F)
do not freeze

Inactive ingredients

benzyl alcohol, light mineral oil, propylene glycol, purified water, sucrose distearate, sucrose stearate

Questions or comments?

Call toll free 1-855-423-2630

Principal Display Panel

compare to Abreva® active ingredient†

Docosanol Cream 10%

Cold Sore / Fever Blister Treatment

non-Prescription medicine to shorten healing time*
Cold sore treatment
For topical use only

NET WT 2 g (0.07 oz)

†This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Abreva®.

* Non-prescription cold sore medicine to shorten healing time and duration of symptpms.

RETAIN THIS INSERT FOR FULL PRODUCT USES, DIRECTIONS AND WARNINGS

DISTRIBUTED BY UNFI

PROVIDENCE, RI 02908 USA

Package Label

EQUALINE Cold Sore Fever Blister Treatment

INGREDIENTS AND APPEARANCE

DOCOSANOL

docosanol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41163-724
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOCOSANOL (UNII: 9G1OE216XY) (DOCOSANOL - UNII:9G1OE216XY)	DOCOSANOL	100 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
BENZYL ALCOHOL (UNII: LKG8494WBH)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SUCROSE DISTEARATE (UNII: 33X4X4B90S)
SUCROSE STEARATE (UNII: 274KW0O50M)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:41163-724-07	1 in 1 PACKAGE	06/01/2021
1		2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA208754	06/01/2021

Labeler - EQUALINE (SuperValu) (006961411)

Revised: 10/2022

Document Id: d32ff607-008e-46f3-94f8-918016489c62

Set id: 7dd527af-878c-4150-86d0-69881b5e3f8f

Version: 2

Effective Time: 20221025